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    GMP Documentation
    GMP Documentation

    We are your partner for the review and creation of GMP documents

    With us, you can quickly and reliably obtain a GMP certificate with GMP-compliant documentation.

    GMP (Good Manufacturing Practice) is often jokingly referred to as "a lot of paper". In fact, GMP-compliant documentation is very extensive and encompasses the entire Pharmaceutical Quality System (PQS).

    Our GMP experts will guide you through the GMP documentation process efficiently. Benefit from the long-term experience of our Valicare documentation experts and achieve GMP-compliant documentation in a safe and relaxed manner. 

    That’s why you should work with us:

    More than 20 years of GMP experience with over 5,000 successful projects
    Preparation and review of all types of GMP documents
    GMP-compliant and audit-ready documentation
    Service-oriented approach and flexible service packages

    We support you with the following topics:

    • Establishment of the pharmaceutical quality management system (PQS)
      You are planning to establish a new PQS and need support? Our experts will make sure you reach your goal quickly and reliably.
    • Optimization of the pharmaceutical quality management system (PQS)
      You already have a PQS in place, but would like to have it audited and optimized externally? Our experienced experts will analyze the current processes, identify optimization potentials, and accompany you through the optimization process.
    • Creation and optimization of individual elements of GMP documentation
      Would you like us to review or create individual documents? We have the right specialists for every part of the GMP documentation.
    • Training on GMP documentation
      You require training or would like to have your employees trained? We are pleased to design a training course according to your needs.

    We offer fixed prices for defined overall packages or, alternatively, invoicing upon proof in the case of continuous support. 

    These GMP services and a comprehensive service portfolio are also available remotely.

    We can support you in the following areas, in terms of content or in terms of documentation only:

    • Site Master File (SMF)
    • Quality Management Handbook (QMH)
    • Qualification Master Plan (QMP)
    • Validation Master Plan (VMP)
    • Hygiene Master Plan
    • Pharmacovigilance System Master File (PSMF)
    • Concept, instructions, templates, plans, and reports
    • We build your qualification system together with you for:
      • Rooms and cleanrooms
      • Monitoring systems
      • Devices and equipment
      • Supply and media systems
    • We support you in preparing qualification documents and in implementing the qualification, with our own templates or according to your existing system. We are at your side –from User Requirement Specification (URS) and technical risk analysis to the release of the qualified premises, facilities, or equipment.
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    • Concept, instructions, templates, plans and reports
    • We set up your validation system in cooperation with you for:
      • Process validation (PV)
      • Computer system validation (CSV)
      • Analytical method validation (AMV)
      • Cleaning validation (CV)
    • We support you in preparing of validation documents and executing the validation including formal risk analyses, using our own templates or according to your existing system.
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    • Specifications, batch documentation, Certificate of Conformity
    • We create development reports that map your pharmaceutical development
    • We describe your processes with all necessary specifications, instructions (manufacturing instructions, operating instructions, hygiene regulations, etc.), and form sheets for documentation (e.g., batch record)
    • Specifications, test instructions, and test protocols, Certificates of Analysis (CoA)
    • We describe your methods with all necessary specifications, instructions (test instructions, operating instructions, hygiene regulations, etc.), and form sheets for documentation (e.g., test protocol, CoA)
    • This also applies to other SOPs, form sheets and lists
    • We support you in procuring and implementing the right document management system, paper-based, electronic, or combined
    • We offer training regarding the contents of a pharmaceutical quality management system as well as for document management and Good Documentation Practice
    • We support your staff in Good Documentation Practice by creating a concept including the instructions, training your employees, and ensuring that your forms are suitable
    • We create concepts with you to ensure data integrity and support you in implementing them
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    We offer all our documentation service packages individually or in combination. You will receive a customized offer for your individual requirements within a few days. Our team looks forward to your call or message.

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    Free first consultation now!

    Free first consultation now!

     

    Dr. Ellen Sons-Brinkmann
    Phone: +49 69 153 293 709

    Contact us

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